NCT02797236

SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

A Phase I Dose Escalation Study to Assess the Safety and Immunogenicity of the SF2a-TT15 Conjugate Vaccine Against S. Flexneri 2a in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.

Detailed description

Subjects will be assigned to one of two cohorts. 1. Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo. 2. Cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant) or matching placebo. Eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum or matching placebo, at a ratio of 3:1, as three single IM injections. There will be an interval of 28(±3) days) between each treatment. The study will be conducted in a stepwise approach in which a "Pioneer" Group of 2 subjects (one receiving the active vaccine and one receiving the matching placebo) will receive the first injection. These subjects will remain in-house for a 24-hours medical observation after the first injection (not required in the subsequent injections) Once it has been established that there are no safety concerns in the non-adjuvanted "Pioneer" Groups (and after no less than 48 hrs), the next "Pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one receiving the matching alum placebo) will be injected. If no safety concerns are raised in this group also, after no less than 48 hrs, the rest of the subjects may receive the first injection.

Conditions

• Shigellosis
• Bacillary Dysentery

Interventions

Type	Name	Description
BIOLOGICAL	SF2a-TT15 vaccine
BIOLOGICAL	SF2a-TT15 vaccine + adjuvant
BIOLOGICAL	Placebo
BIOLOGICAL	Placebo + adjuvant

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-06-13
• Last updated: 2018-04-11

Locations

1 site across 1 country: Israel